Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

November 12, 2020 updated by: MiMedx Group, Inc.

Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Southeastern Center for Clinical Trials
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Weil Foot, Ankle and Orthopedic Institute
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is 30 years or older.
  2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
  3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
  4. Subject must have a VAS pain scale greater than 30.

Exclusion Criteria:

  1. Subject has active infection at the injection site.
  2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
  3. BMI greater than 45 kg/m2
  4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
  5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
  6. Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
  7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
  8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
  9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
  10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
  11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
  12. Subject has had prior radiation at the site
  13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
  14. New diagnosis of gout in the past 6 month
  15. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
  16. Subject has a diagnosis of Osteonecrosis of the knee.
  17. Subject has had a total knee replacement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 4mL amniotic fluid
Amniotic Fluid: 4mL dose of amniotic fluid
Other: Amniotic Fluid
Amniotic Fluid
Active Comparator: 4mL2x amniotic fluid
Amniotic Fluid: 4mL 2x dose of amniotic fluid
Other: Amniotic Fluid
Amniotic Fluid
Placebo Comparator: 4mL Saline Placebo
Normal Saline
Other: Saline Placebo
Saline Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in Pain
Time Frame: 3 month
The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 3 months
subjects who experience a level of improvement in function as assessed by range of motion at 3 months
3 months
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
measurement to assess the patient's opinion about their knee and associated problems by looking at pain, functions of daily living, function in sports and recreation, knee related quality of life and other symptoms
4weeks, 6weeks, 3 months, 16 weeks, 6 months
SF-12 Health Health Survey
Time Frame: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
patient-reported survey assessing patient health
4weeks, 6weeks, 3 months, 16 weeks, 6 months
Activity of Daily Living Questionnaire
Time Frame: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Changes in the subject's physical activity level
4weeks, 6weeks, 3 months, 16 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MiMedx Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OFORT003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings